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Global Partnership to Make Available 120 Million Affordable, Quality COVID-19 Rapid Tests for Low- and Middle-Income Countries

Street scene outside the Lok Nayak Jai Prakash Narayan Hospital, Delhi.December 2017Photo credit: FIND / Ben Phillips

Rapid tests are a fast and accurate way to diagnose patients in a primary healthcare setting

Global partnership feeds healthy supply of rapid COVID-19 tests to low- and middle-income countries 

A set of global agreements reached in September 2020 paved the way for 120 million rapid COVID-19 tests to be distributed to low and middle-income countries.

The Access to COVID-19 Tools (ACT) Accelerator, working with other organizations, concluded these agreements to enable the manufacture, distribution and rollout of these vital diagnostic tools.

At the time, there was a huge unmet need for fast diagnostic testing globally, especially in the low and middle-income bracket.

The Africa Centres for Disease Control and Prevention (Africa CDC), the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid, and World Health Organization (WHO) all worked on this project.

There was a particular focus on making tests available to countries without extensive laboratory facilities or trained health workers to implement molecular (polymerase chain reaction or PCR) tests.

Why is testing crucial in the fight against COVID-19?

Rapid tests are a fast and accurate way to diagnose patients in a primary healthcare setting, as this is where most people access services. 

Rapid tests are also cheaper than laboratory tests. With a fast initial diagnosis, track and trace teams in more remote and rural areas can start work sooner without waiting for laboratory test results. 

Quick results can prevent the virus from spreading in communities. Rural and remote healthcare settings especially need access to rapid testing, as accessing centralized laboratory services can take a long time.

Procurement

The Global Fund made $50-million available to purchase 10 million tests per country.

Distribution

FIND and WHO supported countries in distributing these tests.

Unitaid and the Africa CDC combined resources rollout tests to countries in Africa from October 2020. 

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You’re Part of Something Bigger”: Delivering Lifesaving COVID-19 Diagnostic Tests in South Africa

Health Poverty Action Visiting Hospitals at Kompong Chhnang & Battambong Province

Getting tests into hands: delivering rapid diagnostic tests to South Africa

In June 2021, a large shipment of COVID-19 diagnostic tests procured by the Global Fund through their Pooled Procurement Mechanism arrived in South Africa.

Part of the order was 648 000 rapid antigen tests that produced results within 15 minutes for community health workers and medical personnel working on the front lines.

At the time, the country saw a rapid rise in infections caused by the Delta variant. The rollout of vaccines to the general public only started in July that year, with the elderly getting priority access.

All hands on deck
Logistics personnel interviewed by the Global Fund reported early-morning queues on average 100 metres long at testing sites, as people tried to access possible diagnoses in response to the new infection wave.

The test kits delivered in South Africa were manufactured in South Korea, flown via Ethiopia to a warehouse in Johannesburg, and sorted and distributed throughout the country. 

The supply chain also faced several problems, including a shortage of shipping containers, resulting in delays in deliveries of essential products, such as personal protective equipment. Logistics personnel also feared theft and hijacking.

By 1 July 2021, the Global Fund has procured 21.5 million diagnostic tests worldwide.

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Collaborations lead to apps, toolkits to collect COVID-19 RDT data

Collaboration between organizations is essential to quickly design and develop human-centred health tools to tackle the COVID-19 pandemic. The list below is a collection of various applications and toolkits developed in this way to capture COVID-19 related data.

  1. The COVID-19 Template App, designed by FIND and Dimagi, supports health workers as they administer and record the results of COVID-19 antigen rapid diagnostic tests (RDTs). The application features workflows for patient registration, test initiation, and result capture. 
  1. The RDToolkit: Currently Supported RDTs is a listing of the RDTs that the Rapid Diagnostics Tookit hosts.
  1. FIND and HISP India collaborated to develop a DHIS2-based package for capturing data for RDTs. The resultant COVID-19 RDT Data Capture programme metadata package is available for download.
  1. As part of the ACT-Accelerator, Argusoft added a novel digital health solution to enable RDT capture with FIND. This COVID-19 RDT Data Capture is a MEDplat extension.
  1. ODK partnered with FIND to create a ready-to-use form to help community health workers in collecting data when performing RDTs. Read more on the COVID-19 Antigen RDT form for standards-compliant data.
  1. Medic’s CHT App with COVID-19 RDT Workflows is a community health toolkit to enhance RDT workflows. It also was developed in partnership with FIND. The app is powered by the Community Health Toolkit (CHT).
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Model to improve COVID-19 diagnostic data collection

FIND and PATH have been working together to support the development and implementation of digital tools for the global COVID-19 response.

With more than 400 COVID-19-based digital health tools available, countries need to determine the most appropriate ones for their needs, and how to use them. 

The Digital Square initiative within PATH’s Centre of Digital Excellence has convened a network of global collaborators to streamline a more effective approach to using these tools.

Its goal is to improve COVID-19 diagnostic data and use, which will increase the ability to share and view rapid diagnostic testing data.

To this end, FIND and PATH created a template of data fields relevant to the COVID-19 rapid diagnostic test workflow, called the ACT-A COVID-19 Antigen RDT Data Model.

Aimed at supporting low- and middle-income countries, the common data model is freely available to download.

Read more here

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Call for solution to capture COVID-19 testing data

FIND issues proposals request from digital health solution providers for COVID rapid diagnostic test data capture 

FIND, as co-convener of the ACT-Accelerator (ACT-A) diagnostics pillar, is working towards supporting countries in implementing an effective test-trace-isolate response using digital tools. 

This includes partnering with digital solution providers to speed up development and deployment of a set of minimum functionalities for COVID rapid diagnostic test (RDT) data. 

The idea is to incorporate these functionalities into existing digital tools to be used in low- and middle-income country (LMIC) settings.

FIND therefore issued a Request for Proposals (RFP) to identify and work with developers of existing digital health solutions already in use in LMICs at community level. 

Any organization, institution or entity specializing in developing and implementing digital health solutions for healthcare data collection in LMICs was invited to apply, with potential for further collaboration.

Partners were to be selected through a process which focused on:

  • Current capability to deliver the RFP requirements 
  • Organizational assessment
  • Cost of the project.

This RFP contained three appendixes which provided data points to be captured, target characteristics to be considered, and a response template.

The RFP opened on 7 April 2021, and closed on 28 April 2021. Data collection functionalities and workflows were due to be ready for rollout by the end of June 2021.

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In-house test development for molecular detection of SARS-CoV-2

Roadmap to create diagnostic tests available in English, French and Portuguese.

This document provides guidance on the development of a new, in-house, real-time RT-PCR test for SARS-CoV-2 aimed at laboratories which have established molecular biology capabilities. 

The information – available in English, French and Portuguese – will also provide a roadmap for the creation of new molecular diagnostic tests for other emerging pathogens. 

It acknowledges the constraints  of resource-limited laboratories, and outlines  requirements for good molecular biology practices, including quality control and quality assurance.

Steps to success
When a new virus such as SARS-CoV-2 emerges, laboratories rely on time-tested methods of developing diagnostic tests when commercial assays are unavailable. 

These LDTs are rarely perfect on the first attempt. 

Ideally, these tests continue to develop and gain validation until formally certified for in vitro diagnostic use by a regulatory body.

Most LDTs do not progress to the point of formal certification for use. However, they should still be held to the highest standard of quality possible to mitigate the health and economic impacts of the emerging disease and help protect vulnerable populations.

Read the report here

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Forum discusses research agenda for SARS-CoV-2 antigen rapid diagnostic tests

Participants identify key questions to take technical and programmatic research forward.

ACT-Accelerator diagnostic pillar partners joined in a virtual forum to discuss the development of a collaborative operational research agenda for SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs). 

The forum, held on 29 October 2020, was organized around three breakout groups according to three thematic areas for SARS-CoV-2 Ag-RDTs:

  • Technical research
  • Programmatic research
  • Modelling

Group participants focused on understanding the performance of Ag-RDTs when implemented in real-world settings and across specific populations. 

Priority questions

  • Performance
  • Use cases
  • Samples
  • Bio-safety
  • Quality control
  • Training and delivery
  • Economics and cost.

Participants discussed steps to advance the Ag-RDT research agenda and agreed that there should be multiple future discussions on this. 

Read the report here

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Rapid diagnostic tests for COVID-19

Key takeaway: Both types of RDTs are crucial for effective public health management.

Rapid diagnostic tests (RDTs) for COVID-19 can detect either antigen (Ag) or antibody (Ab), and both types of tests have important roles.

A combination is needed for effective patient management and public health planning.

This May 2020 report outlines general information on Ag- and Ab-detection RDTs for COVID-19, and suggested uses for them.

Polymerase chain reaction (PCR) or Ag

  • Directly detects the virus and should be prioritized for diagnosis and monitoring
  • Prioritize for case management to enable decentralized testing – particularly where PCR testing is limited.

Immune response tests or Ab

  • Tests detecting viral immune response tests can be complementary for clinical care
  • Should be prioritized for seroprevalence and epidemiological purposes
  • Prioritize Ab RDTs for seroprevalence surveys to inform public health measures and testing of contacts to establish previous viral spread.

The value of any test is dependent on factors such as the test performance, or sensitivity/specificity, as well as the epidemiological context, or prevalence in the population where it is used, and timing.

The report also lists unique features of SARS-COV-2 to consider when using RDTs and specifies operational characteristics, such as how to interpret test results. 


Read the report here

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US$7 million investment accelerates availability COVID-19 self-tests in low- and middle-income countries

Key takeaway: Successful applicants to manufacture 240 million low-priced tests a month.

On March 31 2021, FIND launched a request for proposals (RFP) to develop, manufacture, and launch to market COVID-19 self-tests in low- and middle-income countries (LMIC). 

The RFP called for quality-assured and easy-to-use self-tests that were accurate and affordable. It was prepared in the context of the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, co-convened by FIND and the Global Fund.

Innovators, developers and manufacturers of in vitro diagnostics, and LMIC-based diagnostic stakeholders, were invited to submit proposals.

A package of US$7 million was offered in support, funded via grants to FIND from the German Federal Ministry of Education and through KfW and other donors.

International expertiseFrom 80 applicants, contracts were signed with four companies, and their names announced in February 2022:

Each has committed to manufacturing up to 60 million tests per month, priced from US$1–2 per test.FIND will conduct independent clinical evaluations of test performance, with support dependent on meeting project milestones.

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Call to boost access to cheaper rapid diagnostic tests

Key takeaway: RDT agreements boost local manufacturing to supply millions of low-cost, high-quality tests for lower-income nations.

In July 2020 FIND and Unitaid launched a call via the Access to COVID-19 Tools Accelerator Diagnostics Pillar for expressions of interest (EOI) to speed up availability and scale up manufacturing of rapid diagnostic tests (RDTs) for COVID-19.

The EOI was geared towards increasing supply of regulatory approved, fit-for-purpose SARS-CoV-2 Ag RDTs that met WHO criteria of quality, cost and accessibility. This was particularly needed in low- and middle-income countries (LMICs).

Innovators, developers and manufacturers of RDTs and in vitro diagnostics, and LMIC-based diagnostic stakeholders, were invited to submit proposals.

Interventions included:

  • Accelerating late-stage product development and optimization
  • Facilitating technology transfer activities
  • Conducting performance evaluation studies to support regulatory submissions
  • Increasing production capacity
  • Addressing supply chain challenges
  • Strengthening local capacity for development and deployment of new tests within national testing strategies. 

Driving down prices and supporting the use of less invasive specimens to enable faster LMIC uptake were also critical. 

Over 100 applications were received, with 34 selected for review by a panel of external experts. 

A first collaboration, with Premier Medical Corporation in India, was announced in January 2021. By July that year, additional technology transfer agreements were signed with stakeholders in Africa and Latin America.

These included an agreement with DCN Dx to transfer know-how to WAMA Diagnóstica (Brazil), and with Bionote and Mologic to transfer know-how to DIATROPIX of the Institut Pasteur de Dakar (Senegal). 

There is a separate partnership between Viatris (South Africa) and Guangzhou Wondfo Biotech (China).

These agreements will lead to a dramatic increase in local manufacturing, ultimately making more than 250 million low-cost (US$2–2.50) tests available for LMICs.